PA CHAPTER I

Quality

The combination of attributes or characteristics of a product which, when com-

pared to a standard, serves as a basis for measuring the unifromity of the product

and determines its degree of acceptability.

Quality Control

a tool which gives the assurance that a product conforms to standards and specifications through a system of inspection, analysis, action.

Research & Development and Quality Control

Departments working under the Scientific V.P.

Purchasing, Production, Warehouse and Maintenance

Departments working under the Manufacturing V.P.

Errors

may be due to chance or assignable causes such as: materials, machines, methods and men

Formula

is a concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each

Raw Material Specification

- should enumerate the characterisitcs of all the materials that go into the product and the permissible range of purity of each ingredient

- deviation beyond this range may be expected to cause failure of the product to function as planned

Standard Operating Procedure

- this is a step by step method on how to go about a job

- it must spell out all information and instructions

Current Good Manufacturing Practice (CGMP)

- all manufacturing must be done in compliance with this standard:

Finished Product Specification

- this should cover all characteristics that affect the proper performance, purity, safety and stability of the product

Packaging Material Standard

- should be set for everyone that goes around the product i.e. bottles, cans, aluminum foil, etc.

Testing Methods

• are indispensable in assuring conformity to standards.

Defects

• an undesirable characteristics of a product

• it is defined as a failure to conform to specifications

Variable Defects

• a defect which can be measured directly by instrumentss giving dimensions of length, weight, height, thickness, concentration, volume, viscosity, ph or size particles

Attribute Defect

• a defect which cannot be measured directly by instruments

• shows mainly the conformance or nonconformance of the material to specifications

Critical Defect

• a defect which may endanger life or property and may render the product non-functional

Major Defect

• a defect whcih may affect the function of the object and therefore, may render the product useless

Minor Defect

• a defect which does not endanger life or property, nor will it affect the function but nevertheless remains a defect since it is outside the prescribed limits

Ocular Defect

• a defect that is visible

Internal Defect

• defect which is not seen although present

Performance Defect

• defect in function

Materials

a.) Variation between suppliers of same substance

b.) Variation between batches from same supplier

c.) Variation within a batch

Machines

a.) Variation of equipment for the same process

b.) Difference in adjustment of equipment

c.) Aging and improper care

Methods

a.) Inexact procedures

b.) Inadequate procedures

c.) Negligence by chance

Men

a.) Improper working conditions

b.) Inadequate training, and understanding

c.) Dishonesty, fatigue and carelessness

Materials Inspection Section

- inspectors are alert individuals who had experience and who are familiar with the physical characteristics of the materials they same and are well versed in sampling techniques

Analytical Laboratory

- should be in an accessible area and protected from noise and vibration common to manufacturing operations

- in order to perform physical and chemical analysis, the analysts should know the usual gravimetric and volumetric analysis

Biological Testing Laboratory

- the staffs should be well trained and experienced in both simple and complex micorbiological procedures and biological interactions

- sterile conditions should be provided for areas where biological tests are conducted

Specifications and Analytical Development

this section should have a firm background not noly in the principles of quality control and analytical procedures but also in manufacturing, research, product development and in statistics in order to perform the following functions

Quality Coordination Office

This section should be accessible to all manufacturing and packaging operations since documentation is its main responsibility.